Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Exclusion Criteria

• •Candidates will be excluded from the study if any of the following conditions are present:
• •Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
• •Severe chest wall deformity
• •Leukopenia (WBC\<3000 mm3)
• •Acute or chronic anemia (Hb \<90g/l)
• •Platelet count \<100,000 cells/mm3
• •In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
• •Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason
• •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• •History of, or active, endocarditis, unless the endocarditis has been treated \>6 months previous to the procedure
• •History of or current intravenous drug abuse
• •A known hypersensitivity to aspirin or heparin
• •Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\]
• •Major or progressive non-cardiac disease resulting in a life expectancy of \<1yr
• •Obstruction of the central veins preventing advancement of the pulmonary bioprosthesis delivery system to the heart
• •Positive urine or serum pregnancy test in female subjects of child-bearing potential
• •Ileofemoral vessel characteristics that would preclude safe placement of 19 French (F), 22 F and 24 F introducer sheath
• •Contraindication for cardiac magnetic resonance imaging or inability to cooperate with a cardiac magnetic resonance imaging exam
• •Need for concomitant interventional procedures